Counterfeit Medications: A Growing Threat to People with Autism and Epilepsy

 

About 1 in 88 children have autism, says a 2012 CDC report.

Approximately 25 to 35% of these autistics have or will have full-scale seizures.

Other autistic individuals have sub-clinical seizures.

In short, 'seizure-like brain activity, in which there is no obvious effect on muscles but potential effects on brain functioning..., says a 2011 Medical News Today release.

Sadly, there are few alternative or "natural" treatments for epilepsy.

People who suffer with epilepsy rely on pharmaceuticals to control potentially health damaging and life threatening seizure activity. 

Common drugs to treat epilepsy include Lamotrigine (Lamicatal), Levetiracetam (Keppra) and Topiramate (Topamax).

As if parents of autistic children with epilepsy don’t have enough stress, now we need to worry about adulterated and counterfeit medications.

Upwards of 10 percent of drugs worldwide are counterfeit, and in some countries more than half the drug supply is made up of counterfeit drugs, says one FDA report.

Some of these counterfeits are seizure medications.

Majority of fake pharmaceuticals in U.S. are imported from China and India.

Other imposter medications are smuggled into U.S. across Mexican and Canadian borders.

 Another way drugs are compromised is through pharmaceutical cargo theft.

In 2011, thieves got hold of 9 pallets of the epilepsy drug Gabapentin, made by generic drug manufacturer Actavis, according to Securing Pharma.

Apparently, the drugs were being moved by truck, when the trucker decided to stop and get a pack of smokes. He left truck running. That’s when criminals hijacked truck and took off.

How did criminals know the truck had pharmaceuticals on board?

It’s easy to track incoming pharmaceutical shipments.

In fifteen seconds, I found a site called Importers-directory.net.

There it shows an India based company’s (Aurobino) “Import shipment database details” revealing products destined for U.S.

For example, Citalopram (a drug prescribed to some autistic patients) tablets set to arrive on a shown specific date, in Elisabeth, New Jersey.

On another site I found “Top export product information of Sri Aurobindo”, an India based company that manufacturers and exports generic epilepsy drugs to U.S.

Importing drugs via Bombay Air, Aruobino declared ‘mini tablet presses’  ‘pharmaceutical machinery’ and ‘equipment for production of Medi-Cal formulations’, along with “Blister Packing Machines.”

Imagine if criminals get hold of these shipments. Not only do they get medications, but equipment to adulterate and create counterfeit medications. 

Are there other ways medications can be compromised? Yes. Let's take a look.

On import.genius.com/suppliers/m-s-aurobindo-pharma-ltd, you can see that in 2009, Aurobindo Ltd sent pallets of anti-epileptic drugs Levetiracetam and Lamotrigine to U.S. based drug manufacturer Greenstone LLC.

The shipment traveled from India and arrived at Charleston, South Carolina, with Greenstone LLC being the “Consignee” (person to whom shipment is delivered).

But wait. Shipment data lists a freight forwarder under “Notify Party”. So, the actual drug company that sells the drugs isn’t even picking up the drugs.

Hiring freight forwarders is legit, but it shows how pharmaceuticals travel between many hands, are transferred, trucked or stored, thus becoming vulnerable to theft or adulteration, before they eventually end up in someone’s body.

Go to drugs.com/imprints to see generic Keppra levetiracetam from India listed as ‘manufactured/repackaged’ by Greenstone LLC.

So, the Levetiracetam one thinks came from U.S. may originate from India, where it is subsequently shipped to U.S., handled by a broker, who then delivers shipment to another generic company here in U.S. that repackages the drugs and then sells drugs to U.S. pharmacies and hospitals.

U.S. pharmacies, including Kaiser Permanente, provide generic drugs from Greenstone LLC.

Recall Citalopram shipped from India noted above? Turns out in March 26, 2011, Greenstone LLC recalled Citalopram 10mg Tablets (100-count bottle) distributed in the U.S. market.

Why?  Because incorrect labels were placed on pill bottles: by a third-party manufacturer. See my point?

Pharmaceuticals intended for U.S. citizens should not be passing between so many different contacts.

According to a 2011 Interpol news release, during one special operation, custom authorities seized 2.4 million dollars worth of counterfeit drugs, including antibiotics and ANTI-EPILEPTIC pills, originating from 48 countries.

There’s yet another scenario that plays out in counterfeit medication industry.

The compromise can begin when a pharmaceutical raw materials company sells tainted ingredients to a drug manufacturer. Once drugs are manufactured, they are sold to a drug wholesaler. From there, drugs are sold to hospitals and pharmacies. Final destination: disappearing inside the bodies of unsuspecting patients. 

Pharmacists must be alert to threat of counterfeit drugs, says a recent report from the American Pharmacists Association (March/April 2012).

Well, how do you spot a counterfeit pill? Sometimes, fake pills have bigger lettering, bolder colors or uneven imprinted numbers and letters. Or, be chipped or easily crumble. Or have strong odors, usually from toxic fillers like arsenic, ammonia and paint. In some cases, not even experts can visually tell the difference between counterfeit and authentic medications. 


According to a 2007, Science Daily report, " Immunochemists have devised a range of nanoscale materials that can be embedded in drug packaging or in the pills...to distinguish medicines from counterfeits." However, it's unclear how many drug manufacturers use this technology. 

While organized crime is heavily involved in this pharmaceutical nightmare, they aren't the sole reason for adulterated or counterfeit medications. 

Amazingly, pharmaceutical giant GlaxoSmithKline (GSK), maker of the popular epilepsy drug LAMICTAL, plead guilty to distributing adulterated drugs, according to a 2011 CBS news report. One would hope you could at least trust the original maker of the drug. 

As if GSK’s CEO’s take Ecstasy, their website says, “GlaxoSmithKline helps people to do more, feel better and live longer.” By adulterating epilepsy medication? 


According to a June 9th, 2011 New York Times report, UCB, drug manufacturer of Keppra, was fined 34 million dollars for illegally marketing and promoting Keppra for headaches and pain. Never mind no evidence supports this claim and headaches are a major side effect of taking Keppra. But who cares, right? So long as the money is pouring in. 


FDA investigators learned UCB's business planners felt there was a 'higher profit potential' in off label use. I guess there wasn't enough people on Keppra to keep them happy. So, we see that actually helping patients with epilepsy by producing drugs that cure epilepsy, is never the targeted goal. 

In 2011, the FDA sent Mylan Laboratories—a generic maker of Keppra— a warning letter, “During [our] inspection, we identified significant violations of Current Good Manufacturing Practice... for finished Pharmaceuticals... These violations cause your drug product(s) to be adulterated...”  

And then there’s TEVA Pharmaceuticals, another generic manufacturer of Keppra. In 2011, FDA investigators warned TEVA they “identified significant violations of Current Good Manufacturing Practice... violations cause your drug products to be adulterated... Your facility contains shared manufacturing areas where you produce potentially hazardous compounds in multi-product equipment... including drug products intended for the U.S. market”

As if 2011 was the year FDA investigators decided to finally crack down, they also discovered Dr. Reddy's— yet another generic manufacturer of Keppra—Mexico based production plant had failed to “clean manufacturing equipment” or analyze the quality of active ingredients used to make their medications.


What the heck is wrong with these people? How reckless and inconsiderate can a drug company possibly be? It's not like they're making shampoo. The are given a special privilege of making drugs that are prescribed by doctors to allegedly help patients. Any abuse of such a special privilege should carry severe penalties. 

Another threat to our nation's medications is rouge internet pharmaceutical companies selling adulterated and counterfeit medications. 

Don't buy medications from on-line pharmacies because it’s risky, but then again, given what I’ve learned about how corrupt and compromised the pharmaceutical supply chain is, does it even matter? You can’t fully trust any supplier, even legitimate suppliers. 

So now what? The reality is we can’t walk into a drug manufacturer, hover over machines and demand they aren’t adulterating our children’s medications. That’s the FDA’s job. Nor can we detect fake drugs from infiltrating U.S. pharmacies. That’s medical personnel’s job. Nor can we stop cargo thefts. That’s law enforcement’s job.

But there is a job we can do:

1.    Examine every prescription bottle you get for your autistic child

2.    Find name of drug manufacturer (usually in upper right corner). If not clear, call pharmacy and ask them to look up name

3.    Next, check if this particular manufacturer has been cited for chronic violations of Good Manufacturing Practices

4.    Check by typing in name of drug manufacturer, along with words “FDA warning letter”. For example, “Teva” “FDA warning letter”. If there is something, it should come up

5.     Examine pills in every prescription bottle. They should all look, smell and feel the same.

6.    Check number and/or letters on pill. They should MATCH the number/letters on BOTTLE (usually found on lower left side outside the bottle)

7.    You can also visit Drugs.com. At top of page you will find “Pill Identifier”

8.    Type into “Search” the information imprinted on both sides of pill

9.    Peruse page until you spot “results from pill identifier.” Click this link, it should take you to pill you’re looking for

10.                       Pill identifier also shows ingredients of specific pill. This is important, since generic drugs have different ingredients that vary between drug manufacturers.

Lastly, some pharmaceutical companies are trying hard to pinpoint drugs that enhance brain function in autism. I support this, as from my experience, my autistic son benefits from enhancement of receptors 5 Ht-1a, along with other receptors known to be involved with aberrant behaviors in autism. However, all the glorious research and news worthy discoveries are negated if a company can't secure their own product. 

"Be strong. Take courage. Don't be intimidated. Don't give them a second thought because God, your God, is striding ahead of you. He's right there with you. He won't let you down; he won't leave you." Deuteronomy 31:6

Five Things to Remember When Caring  for Non-Verbal Severely-Autistic  Individuals.

1. They can’t tell you if they’re in pain. Watch for changes in behavior, eating, sleeping and mood.  I.e...excessive crying, increased self-injurious behaviors, aggression, increased seizure activity, insomnia, excessive sleeping, muscle weakness, unusual screaming, distended stomach, new changes in eye movement increasingly lethargic.  Sometimes hidden LOW grade chronic infections are present that don’t show up on a blood test.

2. They may have paradoxical reaction to some medications.  Ie...ativan used for calming may cause mania or Valerian Root may cause insomnia.

3. They may refuse to eat and drink several times before finally eating.  If you give up, they won’t receive proper nutrition and hydration. Keep trying. Move them to a different room. Come back. Try again.

4. Food preferences may change. One week the autistic person may prefer crunchy, salty foods. The next, sweet and sour, the next warm foods only, the next cold foods only, and finally, they may refuse any food unless it’s minced or pureed foods.  It’s is critical to learn as much as you can about the autistic individual’s behaviors and preferences.

5. They are smarter than they may appear. Even if they’re sitting alone and appear in own world, they still need stimulation. Give them sensory toys to chew on or play with. Placing them in front of a TV for hours— in some cases— isn’t therapeutic. TV today is not like when I was young. Visual pictures move FAST. Commercials are annoying and loud. It can overexcite the brain and later trigger undesirable behaviors. Sitting in a garden, with a little sunshine, proper hydration, reading them a book and playing Mozart would be a good alternative.

Florida Mom of Severely-Autistic Son with SIB in Crisis

Just saw this Jacksonville, Florida news story (Jacksonville Mother Feels the Pain of Caring for 20-year old Autistic Son) and it is yet another severe autism reality that must be seen. The mom in this video is at her wit's end. Her son, Harley, is destroying the home. He's slapping himself in the face and head. He's still in diapers. He screams. He punches holes in the wall. Anti-psychotics aren't helping. And he's no small guy. At 6'2" and 252 lbs, he looks more like a running back than a young man with profound autism.

Like so many of us who have family members with severe autism, our lives are upside down. How we make it through some days is only by the grace of God. And by having tangible, effective supports. This mom needs help. Sadly, getting help for your severely-autistic family member is never easy. And I mean never. Matt Soergel, the writer of the newspaper story about this case reminds us, "Life with Harley means Sheffield has stepped on a nonstop treadmill of bureaucracy."

Why can't legislators make it easier? Something has to change.

Clearly, in cases like this an expedited process is in order. The mom also suffers from post-traumatic disorder. No surprise there. After all, when you live in a world where your autistic child has been banging, slamming and screaming for years, you tend to get a little jumpy. She says she needs a stiff drink, shoot I'd like to send her a case of Merlot. Apparently, an attorney is helping with the case. It's a travesty that families have to rely on attorneys for a situation that is an obvious on-going crisis.

Ven Sequenzia of Autism Society of Florida reminds us, "A lot of these kids don't end up getting anywhere near what they need...the only way the state responds is to litigation." The mom tried home care, but caregivers sent were "untrained and ill-equipped to take care of him." Not surprising either. It took me months to find nurses who could handle my autistic son. The state agency charged with helping me find caregivers never did. As the mom speaks you can see and hear the urgency and distress. Are we not a nation who prides itself on caring for our most vulnerable citizens? Every night I see commercials about abused animals. And shows telling us to support illegal immigrants and transgender rights. And how we must help poor people in other countries. How is it then that America's severely-autistic citizens in constant crisis remain so invisible?

No doubt, our priorities in this nation are out of order. If only the mainstream media were so obsessed with severe autism we may see some real progress in getting this population the help they so desperately need.

Home Care Vs. Out of Home Care for Autistic Adults

What My Severely-Autistic Adult Son Would Cost California if our Family Didn’t Receive Home Care Support:

According to California’s Legislative Analyst Office, the cost of basic placement for my severely-autistic 23-yr old son at the place he would’ve went (Fairview Developmental Center) if we didn’t fight to keep him home is:  $355,424 a year. Ironically a Fairview team of experts evaluated him at needing “2:1 care” during time of extreme self-injurious behavior.

Source: www.lao.ca.gov/.../developmental-services-budget-update-030112.p

According to a Disability Right’s legal analysis, cost of providing 3- properly trained employees (who split shifts throughout year) for my severely-autistic son’s required 24 hour, 7 day a week 1:1 protective care--would cost the state institution an additional: $193,775 a year.

Total: $549,199. This total doesn’t include outside services that would be utilized to manage my son’s level of complex behavioral and medical care. The total amount also doesn’t include episodic 2:1 staffing, which is a state documented need. Nor does it consider cost of overtime or workman’s comp claims for state employees working with my son’s level of care. Considering these realities, the cost of caring for my son at a state institution rises to over ONE MILLION bucks a year.

Currently, California is providing a fraction of that amount for my son’s care. And it's in the least restrictive environment, at home, with a family and nurses who know and understand his complex needs.

Recall families aren’t obligated under California law to care for adult autistic children. It’s a sacrifice. It’s not always easy.

When families provide home care, they use their own stuff. This means increased wear and tear on home, along with increased expenses. As in: 5-mattresses a year (the number of annual X I’ve had to replace soiled mattresses), broken faucets, or excessive water bills (my son’s obsessed with 3-baths a day plus hot tub is used as emergency intervention for extreme SIB), extra garbage costs (diapers, bed pads, chucks, nursing gloves, air purifiers, food), smoke detectors, heat and air conditioning, etc...

How else to families providing home care save state big bucks? Doing the never ending laundry (many severely-autistic go through 2-3 clothing changes a day), paying for gas to and from medical appointments, recreational costs, special foods, haircuts, sheets, weighted blankets, allergy free pillows, sensory toys, special bathing suits, life vests, towels, shirts, shoes, socks, hats, sunglasses, sunscreen, ice packs, music therapy CD’s, wound care items, oxygen tank fees, special lotions, shampoos, conditioners, vitamins, herbs, toothpaste, jackets, sensory toys, etc...  

Also consider when families receive state-funded home support, family may pay home health aides/nurses directly from a stipend. This means family must use their personal computer, printer, paper, stamps, envelopes, gas, lights, phone and precious time to ensure overall home support is a success. 


Other duties include (all of which I do) recruiting, training, hiring and monitoring home health staff. This isn’t by choice. State officials could never find nurses or health aides for my son, as if they weren’t invested in his home care. I had to go out and recruit my own team of nurses. 

I also provide the medical, behavioral and nutritional management and (along with nurses) oversee medications. For over two decades, the state has completely failed to help my son's behavioral disorder, despite paying over 23 behavioral specialists. 


I, like many parents of autistic children, don’t get a salary for the incredible amount of work we have done or must do. If my son were placed out of home, persons doing this work cost a fortune.


Finally, I'm not opposed to placing an autistic person in an institutional or group home setting. I am opposed to bureaucrats who don't invest time into providing families with effective home based supports. It's easier for them to do abstract, sloppy reports, give up, and then start the out of home placement. 


More effort and funding should be put into securing autistic children and adults home supports. What does that mean? 


It depends on severity of situation. One family may need only 5-hours a day of respite care to maintain the autistic person at home. Another may need 16 hours a day. Still another, 24 hour support. In some cases, a weekend placement is what's needed. 


One of the greatest impediments to securing home care for autistic adults is the lack of skilled caregivers who understand this very unique population. 


You absolutely cannot assign just any nurse or caregiver to a severely-autistic person with self-injurious or aggressive behaviors. Nurses and caregivers must be specially trained and demonstrate skills to handle this unique population. 


There isn't one state program that trains nurses to work with severely-autistic patients in our local hospitals or community settings.